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Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683956
First Posted: May 26, 2008
Last Update Posted: November 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  Purpose
Numerous efforts have focused on the development of closed-loop systems to control anesthesia using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate measures of anesthetic depth. New systems have been recently developed to considerably improve anesthetic control using model-based, patient-adaptive methods. The purpose of this study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in delivering closed-loop, patient-specific hypnosis.

Condition Intervention Phase
Anesthesia, General Device: ReinLoop control software for patient-specific induction and maintenance of anesthesia Drug: Propofol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Evaluation of a Closed-Loop Control System for Patient-Specific Induction and Maintenance of Propofol Hypnosis

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.

Estimated Enrollment: 35
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18-45 years of age
  2. Body mass index (BMI) lower or equal to 25 m2/kg
  3. Subjects must be able to comprehend spoken and written English

Exclusion Criteria:

  1. Any type of psychiatric, neurological, or neuromuscular disorder
  2. Thyroid disease
  3. History of smoking
  4. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. Volunteers will be asked the question: How many drinks are you drinking on your typical day?
  5. Allergy to study medication (propofol), soy, or egg proteins.
  6. History of drug abuse
  7. Chronic or acute use of opioids, or other medications affecting the CNS
  8. Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683956


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Anthony Doufas Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00683956     History of Changes
Other Study ID Numbers: SU-05062008-1141
13305
First Submitted: May 22, 2008
First Posted: May 26, 2008
Last Update Posted: November 24, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General